Both the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices (“respirators”) for health care workers. Respirators protect the user from respiratory hazards by either removing contaminants from the air (air-purifying respirators) or by supplying clean air from another source (air-supplying respirators). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation.

Respirators used by health care workers are air-purifying respirators that generally fall into three types: (1) disposable particulate filtering facepiece respirators (also termed N95s); (2) elastomeric respirators, also known as reusable respirators because they use a replaceable filter; or (3) powered air-purifying air respirators.

To provide input to NIOSH and FDA and to discuss potential next steps to integrate the two agencies' processes to certify and approve N95 respirators for use in health care settings, a workshop was held by the National Academies of Sciences, Engineering, and Medicine in August 2016. The workshop was focused on exploring the strengths and limitations of several current test methods for N95 respirators as well as identifying ongoing research and research needs. This publication summarizes the presentations and discussions from the workshop.

Contents

• The National Academies of SCIENCES · ENGINEERING · MEDICINE
• The National Academies of SCIENCES · ENGINEERING · MEDICINE
• PLANNING COMMITTEE FOR THE WORKSHOP ON THE INTEGRATION OF FDA AND NIOSH PROCESSES USED TO EVALUATE RESPIRATORY PROTECTIVE DEVICES FOR HEALTH CARE WORKERS
• STANDING COMMITTEE ON PERSONAL PROTECTIVE EQUIPMENT FOR WORKPLACE SAFETY AND HEALTH
• Reviewers
• 1. Introduction
  • OPENING REMARKS
• 2. Perspectives from Users, Manufacturers, and Distributors
  • USER PERSPECTIVE: MAYO CLINIC
    Jeffrey Nesbitt.
  • USER PERSPECTIVE: JOHNS HOPKINS UNIVERSTIY
    Geeta Sood.
  • USER PERSPECTIVE: UNIVERSITY OF MARYLAND MEDICAL CENTER
    James Chang.
  • A MANUFACTURER'S PERSPECTIVE
    Craig Colton.
  • A DISTRIBUTOR'S PERSPECTIVE
    Akhil Agrawal.
  • DISCUSSION
• 3. Exploring the State of the Science and Potential Priorities for Research and Standards Development
  • TESTING THE FILTER PENETRATION PERFORMANCE OF RESPIRATORY PROTECTION DEVICES
    Robert Eninger.
  • PARTICLE PENETRATION PATHWAYS
    Sergey Grinshpun.
  • FLUID RESISTANCE TESTING
    Brandon Williams.
  • FLUID RESISTANCE TESTING AND PROTOCOLS
    Steven Elliott.
  • FLAMMABILITY TESTING FOR RESPIRATORS
    Samy Rengasamy.
  • FLAMMABILITY TESTING: TEST METHODS AND STANDARDS
    Roger L. Barker.
  • EVALUATING BIOCOMPATIBILITY
    BiFeng Qian.
  • DISCUSSION
• 4. Options for Post-Market Surveillance
  • OVERVIEW OF THE NIOSH RESPIRATOR APPROVAL PROGRAM AND POST-MARKET ACTIVITIES
    Jeffrey Peterson and James Harris.
  • DISCUSSION
• 5. Potential Next Steps and Priorities
  • NEXT STEPS IN RESEARCH FOR IMPROVING TEST METHODS
    Howard Cohen.
  • ISSUES IN IMPROVING AND STREAMLINING THE INTEGRATION OF FDA AND NIOSH PROCESSES FOR N95S USED IN HEALTH CARE SETTINGS
    Kerri Rupe.
  • PRIORITIES FOR HEALTH CARE WORKERS
    Cecile Rose.
  • DISCUSSION
• References
• APPENDIXES
  • A. Workshop Agenda
  • B. Workshop Participants

Rapporteurs: Joe Alper and Catharyn T. Liverman.

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2017. Integration of FDA and NIOSH processes used to evaluate respiratory protective devices for health care workers: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: 10.17226/23679.